چکیده (انگلیسی):

A near-infrared (NIR) spectroscopic
method to determine content uniformity of a large,
thick tablet using an approach that could facilitate
future validations has been developed. A CT
ibuprofen 800-mg tablet weighs about 1150 mg and
is about 18.6 mm wide and 7.6 mm thick. The FT
NIR spectrometer was optimized for transmission
spectra of the tablets by moving it to the sample
compartment and placing it immediately behind the
tablet. In spite of this dedicated setup, the
transmission spectra obtained were very poor,
indicating that the NIR radiation was not reaching
the detector. The spectra of the tablet improved with
use of a simple preparation in which a flat-face die
applies pressure of 20 000 psi to the tablet; this
reduced the thickness of the tablet from 7.6 mm to
3.6 mm. A calibration model was developed for
tablets with drug content ranging from 70% to 130%
of label. The calibration model was tested using a
validation set of tablets with a drug content of 752,
800, and 848 mg. The results obtained were within
1.5% of the known drug content of the validation set
tablets. Even with the sample preparation, the
content uniformity results of 10 tablets could be
determined using this method in less than 1 hour.
The approach described in this article could also be
used to validate NIR content uniformity methods for
other formulations.